Trial Outcomes & Findings for GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures (NCT NCT03462680)

NCT ID: NCT03462680

Last Updated: 2021-11-17

Results Overview

This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: at the recruitment and after 6 months
• Results posted on: 2021-11-17

Participant Flow

Participant milestones

Measure	Niacin Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo placebo placebo: placebo tablet
Overall Study STARTED	21	26
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Measure	Niacin Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo placebo placebo: placebo tablet
Overall Study Withdrawal by Subject	3	5

Baseline Characteristics

GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures

Baseline characteristics by cohort

Measure	Niacin n=21 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet	Total n=47 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 6 • n=5 Participants	68 years STANDARD_DEVIATION 10.7 • n=7 Participants	68.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
UPDRS III	21.25 units on a scale STANDARD_DEVIATION 15.8 • n=5 Participants	22.4 units on a scale STANDARD_DEVIATION 11.8 • n=7 Participants	21.9 units on a scale STANDARD_DEVIATION 15.3 • n=5 Participants

PRIMARY outcome

Timeframe: at the recruitment and after 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

This is the Unified Parkinson's disease rating scale assessment. The investigators assess I, II, III and V components of the UPDRS. UPDRS 3 is motor skills. Higher scores mean worse outcome. A 0 is minimum and 120 is the maximum.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Unified Parkinson's Disease Rating Scale (UPDRS) Change baseline	21.25 units on a scale Standard Deviation 15.8	22.4 units on a scale Standard Deviation 11.8
Unified Parkinson's Disease Rating Scale (UPDRS) Change 6 months	20.8 units on a scale Standard Deviation 12.4	22.31 units on a scale Standard Deviation 16.5

PRIMARY outcome

Timeframe: baseline and after 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the rapid eye movement (REM) sleep as a percentage.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
REM Sleep Pattern baseline	20.09 percentage of sleep time Standard Deviation 13.36	15.83 percentage of sleep time Standard Deviation 12.1
REM Sleep Pattern 6 months	21.1 percentage of sleep time Standard Deviation 11.6	21.45 percentage of sleep time Standard Deviation 16.3

PRIMARY outcome

Timeframe: At baseline and after 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the deep sleep percentage.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Deep Sleep at baseline	8.17 percentage of deep sleep time Standard Deviation 5.11	8.48 percentage of deep sleep time Standard Deviation 6.07
Deep Sleep 6 months	12.28 percentage of deep sleep time Standard Deviation 16.27	8.32 percentage of deep sleep time Standard Deviation 6.09

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the light sleep percentage.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Light Sleep baseline	49.2 percentage of light sleep time Standard Deviation 17.9	53.5 percentage of light sleep time Standard Deviation 18.2
Light Sleep 6 months	50.9 percentage of light sleep time Standard Deviation 15.6	47.5 percentage of light sleep time Standard Deviation 18.5

PRIMARY outcome

Timeframe: at baseline and 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

This requires an instrument Zeo sleep monitor. Subjects are given instructions how to use it. Sleep sensor patches are supposed to be applied on forehead before going to sleep and the data of quality of sleep is captured overnight. The reported data captures the awake time during night sleep percentage.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Sleep Time - Awake baseline	20.2 percentage of awake-sleep time Standard Deviation 23.23	21.95 percentage of awake-sleep time Standard Deviation 17.4
Sleep Time - Awake 6 month	13.5 percentage of awake-sleep time Standard Deviation 10.3	23 percentage of awake-sleep time Standard Deviation 20.7

PRIMARY outcome

Timeframe: at baseline and after 6 months of treatment

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

It captures mental status and awareness of time, place and surrounding. A zero is minimum and 30 is maximum. Higher score indicates better cognition.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Mini-Mental State Examination (MMSE) Change baseline	29.94 score on a scale Standard Deviation 0.24	29.81 score on a scale Standard Deviation 0.88
Mini-Mental State Examination (MMSE) Change 6 months	29.94 score on a scale Standard Deviation 0.24	29.71 score on a scale Standard Deviation 0.78

PRIMARY outcome

Timeframe: at the baseline and after 6 months of intervention

Population: Stroop test was added after recruitment of few subjects.

It captures understanding of color and its description within a certain time frame when letters and colors do not match. There are only two choices to pick from and the correct choices should be made to proceed to the next one. Correct choices are given one point and incorrect choices delete one point. Maximum number of correct choices per unit time are recorded. Three initial trials are given to understand the test. No minimum or maximum values. Higher numbers indicate better cognition.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=17 Participants placebo placebo: placebo tablet
Stroop Test Change baseline	6.18 number of correct responses/unit time Standard Deviation 7.92	8.13 number of correct responses/unit time Standard Deviation 6.64
Stroop Test Change 6 months	8.37 number of correct responses/unit time Standard Deviation 5.6	8.72 number of correct responses/unit time Standard Deviation 6.86

PRIMARY outcome

Timeframe: at baseline and after 6 months

Population: Patients who completed 6 months were analyzed for this measure (39 subjects).

Fatigue was rated from 0-7 in a fatigue questionnaire. A 0 being the least and 7 being the highest level of fatigue.

Outcome measures

Measure	Niacin n=18 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=21 Participants placebo placebo: placebo tablet
Fatigue Severity Scale baseline	40.3 score on a scale Standard Deviation 11.99	36.7 score on a scale Standard Deviation 13
Fatigue Severity Scale 6 months	38.5 score on a scale Standard Deviation 10.99	36.7 score on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

IL-6 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebrospinal Fluid Changes - Interleukin 6 (IL6) baseline	1.6 pg/ml Standard Deviation 0.5	1.9 pg/ml Standard Deviation 2
Cerebrospinal Fluid Changes - Interleukin 6 (IL6) 6 months	1.2 pg/ml Standard Deviation 0.37	1.2 pg/ml Standard Deviation 0.4

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

IL-10 will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) baseline	0.42 pg/ml Standard Deviation 0.64	0.13 pg/ml Standard Deviation 0.16
Cerebrospinal Fluid Changes - Interleukin 10 (IL-10) 6 months	0.09 pg/ml Standard Deviation 0.01	0.08 pg/ml Standard Deviation 0.04

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: A subset of groups were analyzed.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=23 Participants placebo placebo: placebo tablet
Niacin Metabolite in Urine - Niacin baseline	1826.8 ng/L Standard Deviation 663.2	1533 ng/L Standard Deviation 895.9
Niacin Metabolite in Urine - Niacin 6 months	1913.8 ng/L Standard Deviation 481	1660.6 ng/L Standard Deviation 431.7

SECONDARY outcome

Timeframe: at baseline and 6 months

Population: A subset of subjects were randomly selected for this analysis.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=23 Participants placebo placebo: placebo tablet
Niacin Metabolites in Urine - NAM Nicotinamide baseline	815.5 ng/L Standard Deviation 1155	205.8 ng/L Standard Deviation 312.99
Niacin Metabolites in Urine - NAM Nicotinamide 6 months	1140.3 ng/L Standard Deviation 1058.4	685.4 ng/L Standard Deviation 709.3

SECONDARY outcome

Timeframe: baseline and 6 months

Population: A subset of subjects were randomly selected for this analysis.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=22 Participants placebo placebo: placebo tablet
Niacin Changes in Plasma - Niacin baseline	68.5 nM/L Standard Deviation 95.96	55.8 nM/L Standard Deviation 88.3
Niacin Changes in Plasma - Niacin 6 months	80.83 nM/L Standard Deviation 92.4	92.2 nM/L Standard Deviation 59.1

SECONDARY outcome

Timeframe: at baseline and 6 months

Population: Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. Undetectable values are reported as zero. A subset of the groups were analyzed.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=22 Participants placebo placebo: placebo tablet
Niacin Changes in Plasma - NUA Nicotinuric Acid at baseline	0 nM/L Standard Deviation 0	4.99 nM/L Standard Deviation 17.98
Niacin Changes in Plasma - NUA Nicotinuric Acid 6 months	313.9 nM/L Standard Deviation 442.7	0.38 nM/L Standard Deviation 1.53

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

IL-8 cytokine levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebrospinal Fluid Changes - Interleukin 8 (IL8) baseline	62.9 pg/ml Standard Deviation 5.27	102.5 pg/ml Standard Deviation 74.2
Cerebrospinal Fluid Changes - Interleukin 8 (IL8) 6 months	91.6 pg/ml Standard Deviation 51.2	77.9 pg/ml Standard Deviation 19

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels. A subset of the groups were analyzed.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=23 Participants placebo placebo: placebo tablet
Niacin Metabolite in Urine - Nicotinuric Acid NUA at baseline	3565.3 ng/L Standard Deviation 7364.8	1021.8 ng/L Standard Deviation 4538.7
Niacin Metabolite in Urine - Nicotinuric Acid NUA 6 months	20132.9 ng/L Standard Deviation 26789.4	2803.7 ng/L Standard Deviation 8459.9

SECONDARY outcome

Timeframe: at baseline and 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

IL-1beta levels were tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
CSF Fluid Changes - Interleukin 1B (IL-1B) Baseline	0.56 pg/ml Standard Deviation 0.8	0.28 pg/ml Standard Deviation 0.14
CSF Fluid Changes - Interleukin 1B (IL-1B) 6 months	0.21 pg/ml Standard Deviation 0.06	0.22 pg/ml Standard Deviation 0.07

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP-1 beta here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) baseline	14.7 pico grams per ml Standard Deviation 5.02	9.3 pico grams per ml Standard Deviation 2.2
Cerebrospinal Fluid (CSF) Changes - Macrophage Inflammatory Protein 1 Beta (MIP 1 Beta) 6 months	15.9 pico grams per ml Standard Deviation 1.3	7.7 pico grams per ml Standard Deviation 4.2

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: A subset of subjects were randomly selected for this measure and all the data is recorded here that was captured.

The blood is tested to report G-protein coupled receptor 109A (GPR109A) levels in macrophages in M1 and M2 populations.

Outcome measures

Measure	Niacin n=12 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=17 Participants placebo placebo: placebo tablet
Macrophage Changes baseline	54.08 percentage of macrophages Standard Deviation 4.08	56 percentage of macrophages Standard Deviation 4.5
Macrophage Changes 6 months	48.92 percentage of macrophages Standard Deviation 3.9	54.5 percentage of macrophages Standard Deviation 5.2

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: A subset of subjects were randomly selected for this analysis.

Plasma and urine samples will be tested to report levels of niacin and its metabolites. Higher value indicates higher niacin levels.

Outcome measures

Measure	Niacin n=15 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=22 Participants placebo placebo: placebo tablet
Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) baseline	0.43 uM/L Standard Deviation 0.30	0.34 uM/L Standard Deviation 0.19
Niacin Metabolite Changes in Plasma - Nicotinamide (NAM) 6 months	1.07 uM/L Standard Deviation 0.46	0.38 uM/L Standard Deviation 0.15

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IF-gamma beta here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
CSF Changes in Interferon Gamma (IF-gamma) baseline	0.21 pg/ml Standard Deviation 0.3	0.39 pg/ml Standard Deviation 0.39
CSF Changes in Interferon Gamma (IF-gamma) 6 months	2.2 pg/ml Standard Deviation 2.3	0.89 pg/ml Standard Deviation 0.52

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) baseline	0.53 pg/ml Standard Deviation 0.87	0.18 pg/ml Standard Deviation 0.62
CSF Changes - Tumor Necrosis Factor - Alpha (TNF-alpha) 6 months	0.23 pg/ml Standard Deviation 0.05	0.2 pg/ml Standard Deviation 0.31

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of IP-10 here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) baseline	359.8 pg/ml Standard Deviation 193.5	512 pg/ml Standard Deviation 304.8
Cerebral Spinal Fluid Changes - Interferon Gamma Induced Protein -10 (IP-10) 6 months	936.2 pg/ml Standard Deviation 1018	514.5 pg/ml Standard Deviation 351.1

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: Not all subjects donated CSF. All CSF samples are recorded here.

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MCP4 here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) baseline	24.6 pg/ml Standard Deviation 2.03	7.3 pg/ml Standard Deviation 8.1
Cerebral Spinal Fluid (CSF) Changes - Monocyte Chemoattractant Protein 4 (MCP4) 6 months	3.9 pg/ml Standard Deviation 5.6	6.7 pg/ml Standard Deviation 5.09

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in cerebral spinal fluid (CSF) at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.

Outcome measures

Measure	Niacin n=3 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=10 Participants placebo placebo: placebo tablet
Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha baseline	17.8 pg/ml Standard Deviation 6	18.7 pg/ml Standard Deviation 3.8
Cerebral Spinal Fluid (CSF) Changes - MIP1-alpha 6 months	20.5 pg/ml Standard Deviation 18.2	17.3 pg/ml Standard Deviation 9.8

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IF-gamma here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IF Gamma baseline	16.2 pg/ml Standard Deviation 15.6	21 pg/ml Standard Deviation 33.1
Plasma Cytokines - IF Gamma 6 months	84.8 pg/ml Standard Deviation 287.7	15.95 pg/ml Standard Deviation 19.3

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-10 here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IL-10 baseline	0.41 pg/ml Standard Deviation 0.28	0.41 pg/ml Standard Deviation 0.34
Plasma Cytokines - IL-10 6 months	0.5 pg/ml Standard Deviation 0.64	0.41 pg/ml Standard Deviation 0.28

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-1B here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IL1-B baseline	0.32 pg/ml Standard Deviation 0.34	0.37 pg/ml Standard Deviation 0.41
Plasma Cytokines - IL1-B 6 months	0.23 pg/ml Standard Deviation 0.17	0.29 pg/ml Standard Deviation 0.28

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-6 here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IL-6 baseline	5.7 pg/ml Standard Deviation 17.8	8.7 pg/ml Standard Deviation 34.2
Plasma Cytokines - IL-6 6 months	2.97 pg/ml Standard Deviation 4.25	11.04 pg/ml Standard Deviation 40.7

SECONDARY outcome

Timeframe: at baseline and after 6 Months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IL-8 here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IL-8 baseline	6.7 pg/ml Standard Deviation 2.2	6.2 pg/ml Standard Deviation 2.1
Plasma Cytokines - IL-8 6 months	8.1 pg/ml Standard Deviation 3.5	6.6 pg/ml Standard Deviation 2.8

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of TNF-alpha here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - TNF-alpha baseline	2.05 pg/ml Standard Deviation 4.7	0.96 pg/ml Standard Deviation 0.29
Plasma Cytokines - TNF-alpha 6 months	2.26 pg/ml Standard Deviation 5.2	1.0 pg/ml Standard Deviation 0.31

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of IP-10 here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - IP-10 baseline	443.3 pg/ml Standard Deviation 197.3	402.7 pg/ml Standard Deviation 252.5
Plasma Cytokines - IP-10 6 months	542.1 pg/ml Standard Deviation 295.8	355.4 pg/ml Standard Deviation 158.6

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MCP-4 here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - MCP-4 baseline	112.3 pg/ml Standard Deviation 73.8	104.6 pg/ml Standard Deviation 35.7
Plasma Cytokines - MCP-4 6 months	106.4 pg/ml Standard Deviation 44	90.7 pg/ml Standard Deviation 41.3

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-alpha here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - MIP1-alpha baseline	23.3 pg/ml Standard Deviation 20.5	42.1 pg/ml Standard Deviation 116.7
Plasma Cytokines - MIP1-alpha 6 months	23.2 pg/ml Standard Deviation 9.3	38.9 pg/ml Standard Deviation 75.5

SECONDARY outcome

Timeframe: at baseline and after 6 months

Inflammatory and non-inflammatory cytokines levels will be tested in plasma at baseline and 6 months after intervention. We are reporting levels of MIP1-beta here.

Outcome measures

Measure	Niacin n=20 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 Participants placebo placebo: placebo tablet
Plasma Cytokines - MIP1-beta baseline	69.3 pg/ml Standard Deviation 26.1	65.8 pg/ml Standard Deviation 29.8
Plasma Cytokines - MIP1-beta 6 months	65.5 pg/ml Standard Deviation 34.5	56 pg/ml Standard Deviation 24

SECONDARY outcome

Timeframe: at baseline and after 6 months

Population: a subset of the groups were analyzed.

Plasma serotonin levels

Outcome measures

Measure	Niacin n=16 Participants Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=14 Participants placebo placebo: placebo tablet
Plasma Levels - Serotonin baseline	84.2 mg/dL Standard Deviation 68.2	89.6 mg/dL Standard Deviation 60.5
Plasma Levels - Serotonin 6 months	83 mg/dL Standard Deviation 75.2	64.2 mg/dL Standard Deviation 44.5

Adverse Events

Niacin

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Niacin n=21 participants at risk Niacin 250 mg is compared to placebo tablet. niacin: Niacin or nicotinic acid 250 mg tablets	Placebo n=26 participants at risk placebo placebo: placebo tablet
Blood and lymphatic system disorders flushing	33.3% 7/21 • Number of events 7 • 6 months	0.00% 0/26 • 6 months

Additional Information

Dr. Chandramohan Wakade

Charlie Norwood VAMC

Phone: 706-733-0188

Email: chandramohan.wakade@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place